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What is Exclusivity and types of exclusiveties
Exclusivity and their types: Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. It prevents the submission or effective approval of ANDAs or applications described in Section 505(b)(2) of the Act, and was designed to promote a balance between new drug innovation and generic drug competition. Types of exclusiveties: NDA exclusiveties Orphan Drug Exclusivity (ODE) – 7 years New Chemical Entity Exclusivity (NCE) – 5 years Generating Antibiotic Incentives Now (GAIN) Exclusivity– 5 years added to certain exclusivities New Clinical Investigation Exclusivity – 3 years Pediatric Exclusivity (PED) – 6 months added to existing Patents/Exclusivity ANDA exclusivities: Patent Challenge (PC) – 180 days (this exclusivity is for ANDAs only) Competitive Generic Therapy (CGT) - 180 days (this exclusivity is for ANDAs only)